Modes of Ventilation During Laparoscopic Bariatric Surgery

Bariatric Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890564
• Other study ID #: IRB12-00783
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: March 31, 2014
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical visualization. Although effective in facilitating the procedure, there are respiratory consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and increase closing capacity resulting in increased resistance, decreased compliance, and increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to determine which is better able to support oxygenation and ventilation while limiting the peak inflating pressure (PIP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 20 Years

Eligibility

Inclusion Criteria:

• Laparoscopic bariatric surgery requiring intra-arterial blood pressure monitoring, age 14-20 years.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Other:
• Pressure controlled ventilation
For pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath.
• Volume controlled ventilation
For volume controlled ventilation, the tidal volume is set.
• PRVC ventilation
Pressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate	Heart rate will be assessed every 5 mins. during each 30 minute mode of ventilation.	Baseline to 30 mins.	No
Secondary	Change in blood pressure	Blood pressure will be recorded every 5 mins. during each 30 minute mode of ventilation.	Baseline to 30 mins.	No
Secondary	Blood gas	Blood gas will be obtained at the end of each 30 minute mode of ventilation.	30 mins.	No